METHODS: This is a randomized, placebo-controlled, double-blind single-center trial of 2-week treatment with the TSPO ligand etifoxine versus placebo in depressive patients. Main eligibility criteria: male or female individuals aged 18 to 65 years with unipolar/bipolar depressive disorder with no other psychiatric main diagnosis or acute neurological/somatic disorder or drug/alcohol dependence during their lifetime. The primary endpoint is the time point at which 50% of the maximal effect has occurred (ET50) estimated by the scores of the Hamilton Depression Scale (HAMD-21). A total of 20 patients per group are needed to detect changes of therapeutic efficacy about 5% and changes of ET50 about 10% with a power of 70%. Assuming a drop-out rate of 10-20%, 50 patients will be randomized in total. The study will be conducted at the Department of Psychiatry and Psychotherapy of the University of Regensburg.
CONCLUSIONS: This study will provide a first proof-of-concept on the potential of the TSPO ligand etifoxine in the treatment of depressive disorders.
BACKGROUND: Clinical Trials Register (EudraCT number: 2021-006773-38 , registration date: 14 September 2022) and German Register of Clinical Studies (DRKS number: DRKS00031099 , registration date: 23 January 2023).
方法:这是一个随机的,安慰剂对照,在抑郁症患者中使用TSPO配体依替福辛与安慰剂治疗2周的双盲单中心试验。主要资格标准:18至65岁的男性或女性患有单相/双相抑郁障碍,在其一生中没有其他精神病主要诊断或急性神经/躯体障碍或药物/酒精依赖。主要终点是通过汉密尔顿抑郁量表(HAMD-21)的评分估计的最大效果的50%(ET50)发生的时间点。每组总共需要20名患者以检测约5%的治疗功效变化和约10%的ET50变化,功效为70%。假设辍学率为10-20%,总共将随机分配50名患者。该研究将在雷根斯堡大学精神病学和心理治疗系进行。
结论:这项研究将首次证明TSPO配体依替福辛治疗抑郁症的潜力。
背景:临床试验注册(EudraCT编号:2021-006773-38,注册日期:2022年9月14日)和德国临床研究注册(DRKS编号:DRKS00031099,注册日期:2023年1月23日)。